Safety IV catheter infusion device

ABSTRACT

A device for delivering an IV catheter to an IV infusion site is disclosed. The device includes a cylindrical housing adapted to fit into the hand of the clinician. A catheter assembly is disposed in the housing and can be advanced to an extended position and retracted. The catheter assembly includes a needle adapted to be inserted into the vein and the catheter is mounted on the needle to allow the catheter to be removed at will. The catheter assembly is rotated as the needle is inserted into the vein. Preferably the catheter assembly is rotated during the insertion of the needle and catheter. After the needle and catheter are inserted into the vein, the needle is retracted into the housing leaving the catheter in place. The housing and the needle can now be discarded.

BACKGROUND OF THE INVENTION

[0001] a. Field of Invention

[0002] This invention pertains to a device used to establish an IVcatheter in a patient. More particularly, the invention pertains to asafety infusion device that includes a handpiece used to store and toselectively extend the IV catheter so that it can be introduced into thepatient, the handpiece being constructed and arranged to insure that theIV catheter and the so-called underlying needle can be retracted intothe barrel at will to protect clinicians from accidental needlesticks.

[0003] b. Description of the Prior Art

[0004] IV infusion is one of the most widely used procedures performedin hospitals and other healthcare provider sites. These infusionsinvolve continuously injecting one or more liquids into the veins of apatient to achieve various results. Simple infusion systems may consistof a catheter inserted into the vein and secured to the patient, a poleholding a bottle or bag used as the source of the liquid, a flexibletube feeding the liquid to the catheter either directly, or though somekind of fluid control device. More complex devices include fusion pumpsthat can deliver fluids to the patient at carefully metered rates usingspecific profiles.

[0005] However, independent of which infusion system is used, the IVcatheter must first be established. Many different devices are used toperform this step. A popular system consists of a cylindricalreceptacle. A hollow steel needle is attached co-axially to one end ofthe receptacle. A hollow catheter is mounted on the steel needle in acoaxial arrangement. The hollow catheter has a shaft, preferably made ofa plastic material and terminating in a standard connector, such as amale Luer lock. A spring is disposed in the receptacle so that when alatch mounted on the receptacle is activated, the steel needle separatesfrom the catheter and is snapped into the receptacle. Once the steelneedle is snapped into the receptacle, it is locked in place so that itcannot be extended and reused. Since the needle and the catheter arenormally exposed, a protective cap is generally provided over theneedle.

[0006] Using this type of system a catheter is established as follows.First, the clinician finds and preps a proper site on the skin. Next,the system is removed from a sealed enclosure, and its protective cap isremoved. The needle and the catheter mounted thereon are insertedthrough the skin until the tip of the needle and the catheter reaches apredetermined site. The catheter is then secured with the forefinger ofone hand and the latch is activated to cause the needle to snap into thereceptacle before a needlestick. The receptacle with the captured needleis then disposed. Systems of this kind are available from BectonDickinson of Franklin Lakes, N.J.; Johnson & Johnson Medical, Inc. ofArlington, Tex., and described in the following patents, incorporatedherein by reference: 5,688,249 5,520,654 5,304,136 5,700,250 5,141,4975,683,365 5,755,709 ^( D378,405) 5,348,544 5,749,857 5,755,709 5,411,4865,792,122 5,795,339 5,676,658 ^( D381,418) 5,690,619

[0007] However, these systems are not satisfactory for several reasons.As is well known in the art, the catheter has to extend into a vein andmust be oriented properly in order for it to be effective. However, veryoften clinicians cannot find the proper vein or the proper infusion siteon their first try. Therefore, after the needle and catheter have beeninserted, the whole system becomes contaminated. Often, before thesystem can be reinserted, a new site has to be found and prepared.

[0008] The clinician, especially if she is alone, cannot select andprepare a new site while holding the contaminated system and thereforemust make a decision on what to do with it. At least one manufacturersuggests that the system should be discarded. However, obviously, thisis a wasteful step.

[0009] The clinician can also decide to recap the needle and then placeit on a horizontal position. However, this process requires two handsand is exactly the situation that subjects people to inadvertentneedlesticks.

[0010] Another disadvantage of existing systems is that they normallyrequire a linear or translational motion of the needle during insertion.This is disadvantageous because it causes the needle to bend therebycausing pain to the patient. Moreover, if the needle bends duringinsertion, it will miss the vein and the process has to be repeated.

[0011] Commonly assigned application Ser. No. 09/506,484 filed Feb. 17,2000, entitled HAND-PIECE FOR INJECTION DEVICE WITH A RETRACTABLE ANDROTATING NEEDLE, now ______ and incorporated herein by reference,discloses an injection device with a barrel from which a needle isselectively extended and retracted using a translational and rotationalmotion for dispensing an anesthetic to a patient.

[0012] Commonly assigned patent application Ser. No. 09/745,751 filedDec. 21, 2000, entitled METHOD OF PERFORMING AN INJECTION USING ABI-DIRECTIONAL ROTATIONAL INSERTION TECHNIQUE, now ______ andincorporated herein by reference discloses the advantages of using abi-directional rotational technique for dispensing anesthetics.

OBJECTIVES AND SUMMARY OF THE INVENTION

[0013] An objective of the present invention is to provide a system forestablishing a catheter which overcomes the above-mentioneddisadvantages.

[0014] A further objective is to provide a system that can be usedeasily by clinicians.

[0015] Other objectives and advantages will become apparent from thefollowing description.

[0016] Briefly, the subject application pertains to a device forestablishing an IV catheter by a clinician. The device includes ahousing sized and shaped to fit in the hand of the clinician; a catheterassembly including a catheter member with a front portion adapted to beinserted into the vein of a patient; and a control member adapted toreciprocate the catheter assembly within said housing between aretracted position in which said catheter assembly is completelycontained in said housing and an extended position in which saidcatheter member extends outwardly of said housing. A catheter member canbe removably attached to the catheter assembly so that it can be removedin the extended position.

[0017] The catheter assembly includes a needle member with a needleextending outwardly of the housing when the catheter member is in theextended position. The needle is arranged and constructed for insertionin the vein with the catheter member being telescopically associatedwith the needle member. The catheter member is removably attached to theneedle member.

[0018] In one embodiment the catheter member and the housing cooperateto rotate the catheter assembly about a longitudinal axis as thecatheter assembly is reciprocated by said control member.

[0019] The device also can include locking means for locking thecatheter assembly or the needle after the catheter replacement withrespect to the housing. These locking means can be adapted to lock thecatheter assembly in either the retracted position or the extendedposition. In addition, the control member can be disabled by the use ofthe same, or a different locking means so that after the catheterelement is properly established, the needle used to establish thecatheter cannot be reused.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020]FIG. 1 shows a sectional side view of a device in a retractedposition constructed in accordance with this invention;

[0021]FIG. 2 shows a sectional side view of the device of FIG. 1 in theextended position;

[0022]FIG. 3 shows a sectional side view of the device of FIG. 1 in theextended position with the catheter partly removed;

[0023]FIG. 4 shows a sectional side view of the device of FIG. 1 in theextended position with the catheter completely removed;

[0024]FIG. 5 shows a sectional side view of the device of FIG. 1 withthe needle retracted and the catheter removed;

[0025]FIG. 6 shows an orthogonal view of a barrel for the device of FIG.1;

[0026]FIG. 7 shows an orthogonal view of a control button;

[0027]FIG. 8 shows an orthogonal view of the piston for the device ofFIG. 1;

[0028]FIG. 9 shows a side view of the needle member for the device ofFIG. 1; and

[0029]FIG. 10 shows a side view of the catheter for the device of FIG.1.

DETAILED DESCRIPTION OF THE INVENTION

[0030] Referring now to the Figures, a device 10 constructed inaccordance with this invention consists of a cylindrical housing orbarrel 12 having an outer surface 14, an inner surface 16, a front end18 and a rear end 20. An end piece 22 is attached to the rear end 20 ofthe barrel. The barrel 12 defines a cylindrical housing.

[0031] As shown in FIG. 1, a catheter assembly 21 is provided in thebarrel 12. This catheter assembly is biased toward a retracted positionby a coil spring 23.

[0032]FIGS. 6 and 6A show more details of the barrel 12. It includes alongitudinal slot 24. The slot 24 is formed with two ledges 26 extendingalong the sides of the slot 24. These ledges terminate at a gap near thefront end 18 to define a front key 28. In addition, gaps in the ledges26 near the rear end 20 define a rear key 30. Two radial ribs 32 form anouter surface 14 of the barrel 12 to provide a better grip. At the rearend of the slot 24 a portion of the barrel is cut to form an arcuatetongue 34. The purpose of this tongue 34 is described in more detailbelow. The barrel is preferably made of a plastic material and ispreferably transparent so that the clinician can see its contents. Forexample, the barrel could be made of an acrylic-based multipolymer suchas Cyrolite #GS-90.

[0033] As seen in FIG. 1, the inside surface 16 of the barrel 12 isformed with a helical groove 36. The rear end 20 is threaded. The frontend 18 is formed with an annular end wall 38 with an orifice 40.

[0034] The catheter assembly 21 consists of a piston 50 shown in detailin FIG. 8, a catheter member 52 and a needle member 54. The piston isformed of an axle 56 supporting a rear hub 58, a center hub 60 and afront hub 62. The rear and front hubs 58, 62 have approximately the sameradial dimension and they are sized to allow the piston 50 to fit intothe barrel 12 with the hubs 58, 62 slidingly engaging the inner surface16. The axial spacing between the two hubs is sufficient to stabilizethe piston 50 and the elements attached thereto (and described below) asthey reciprocate through the barrel 12. The center hub 60 has a smallerdiameter and a somewhat curved cross section. The circumferentialsurface of hub 62 is optionally provided with a knob 64 which is sizedand shaped to fit into helical groove 36. Therefore, as the piston 50 isreciprocated through the barrel, it is also rotated about itslongitudinal axis by the caming action on the knob 64 as it travelsthrough groove 36.

[0035] Hub 62 also includes a tubular wall 66 disposed about an endportion 68 of axle 56. The inner surface of the tubular wall 66 isformed with a helical groove 70. The wall 66 and the end portion 68cooperate to define a female Luer lock 72.

[0036] Details of the needle member 54 are shown in FIG. 9. It includesa disk 80, a cylindrical body 82, a frustoconical extension 84 and ahollow steel needle 86. These elements are attached to each other asshown. The disk 80 is sized and shaped so that it can be introduced intothe Luer lock 72. In this manner, the needle member 54 is firmlyattached to the piston 50. The needle member 54 can be secured to thepiston 50 by other means as well, for example, by using an adhesive.

[0037] As best seen in FIGS. 3 and 10, the catheter member 52 is formedwith a hollow substantially cylindrical body 90 with a rear portion 92which has a relatively large diameter. The body 90 also has a frontportion 94 which is much thinner than the rest of the body 90. The body90 also includes several circumferential ribs 96 forming a grip for thecatheter. A portion of one of the ribs is extended radially to form atab 98.

[0038] The catheter member 52 is made of a flexible plastic material.Preferably catheter member 52 is somewhat translucent.

[0039] The catheter member 52 and the needle member 54 are sized andshaped so that the catheter member 52 fits over the needle member 54 asshown in FIG. 2 with the steel needle 86 extending through and beyondthe front portion 94. Moreover, the rear portion 92 is sized to form aninterference fit with the extension 84. The catheter member 52 is freelyremovable by a clinician from the needle member 54. Of course, there issufficient interference fit provided to insure that the catheter member54 does not separate easily from the needle member without substantialforce applied thereto. This force may be applied to tab 98 as explainedin more detail below.

[0040] Finally, the device 10 includes a control member 100 shown inmore detail in FIG. 7. The control member 100 is formed of an upper body102, a lower body 104 and an intermediate portion 106. The lower body102 is formed with an arcuate surface 108 designed to conform to theshape of the hub 60 on piston 50. The upper body 102 is formed with twowings 110, 112 and a depression 114 defined therebetween. The depression114 is sized and shaped to accommodate the finger of a clinician. Thewing 112 is formed with a tab 116 extending downwardly and is sized andshaped to fit into the keys 30 and 32 on barrel 12. The control member100 is made of a plastic material.

[0041] The control member 100 is sized and shaped to fit into the slot24 with the upper body 102 disposed outside the barrel 12 and riding onthe ledges 26 and the lower body 104 being disposed inside the barrelwith the hub 60 being captured by curved surface 108.

[0042] The device 10 is assembled by attaching the catheter member 52 tothe needle element 54 and attaching the needle element to the piston 50,thereby completing the catheter assembly 21. The spring 23 and catheterassembly 21 are then inserted through a hole (not shown) in the rear end20 of barrel 12. The control member 100 is also mounted on the barrel12. Next, the end piece 22 thereto by screwing the same over the threadsof the rear end. Preferably and adhesive is also used to insure that theend piece 22 does not separate from the barrel. Alternatively, the endpiece 22 is attached to the barrel 12 without any threading action. Oncethe end piece is installed, the elements described above are captured bythe barrel (except for the catheter member 52) and cannot be removedwithout breakage.

[0043] Initially the elements of the device 10 are arranged in a closedor retracted position as shown in FIG. 1. Spring 23 has a diameter whichis slightly larger than the diameter of wall 66. In this retractedposition, the spring 23 is expanded and applies a biasing force betweenthe end wall 38 of the barrel 12 and the wall 66 on piston 50. Thecontrol member 100 is positioned over the piston 50 with the hub 60being captured by the curved surface 108.

[0044] The control member 100 is formed so that its tab 116 extendsdownwardly in the rear key 32 of slot 26. Moreover the control member100 is formed and arranged so that as the control member 100 is shiftedto the right to the retracted position, a bottom wall 118 of wing 110(shown in FIG. 7) comes into contact with the end of finger 128. Thefinger 128, being slightly higher, and in effect pushes the wind 110slightly upward as well. As a result, the opposite wind 112 with the tab116 is pushed downward into the key 30. In this manner the controlmember 100 and the catheter assembly 21 is locked into the retractedposition. The device 10 is sealed in a suitable package (not shown) andstored in this position.

[0045] The device 10 is used to establish the catheter member 52 asfollows. Typically, an infusion procedure is initiated by a clinician byselecting and prepping the infusion site. The clinician then removes thedevice 10 from its package and holds it in a pinching grip. In this gripthe thumb is positioned on the control member 100, and the remainingfingers being wrapped around the barrel to stabilize it. The device 10is sized and shaped so that in this pinching grip, the pinky fingerwraps around the end piece 22.

[0046] The clinician then pushes on the wing 110 axially inward causingthe top body to twist slightly radially inward, and lift the tab 116 outof rear key 32. This action unlocks the control member 100. Next, theclinician advances the control member 100 slightly forward. Because thesurface 108 captures the hub 60, this movement forces the whole catheterassembly 21 to move forward as well. The clinician continues thetranslation of the control member 100 forward until a portion of theneedle 96 extends through the hole 40 (FIG. 6).

[0047] Next, the clinician positions the device 10 next to the infusionsite with the tip of the needle 86 resting against the skin. Theclinician then continues to advance the control member 100 until itreaches the front key 30. The clinician can lock the control member 100and the catheter 21 by pushing the wind 112 inwardly thereby causing thetab 112 to pivot counterclockwise and engage front key 30. In thisposition, a portion of needle member 54 and most of the catheter member52 extend out of the barrel 12 as shown in FIG. 2. This position is theextended position of the device.

[0048] It should be appreciated that as the control member 100 isadvanced from the rear key 30 to the front key 30 in a translationalmotion through the slot 26, because of the caming action between theknob 64 and spiral groove 36, the catheter assembly 21 is translatedforward as well from the retracted to the extended position, and issimultaneously rotated about its longitudinal axis and the longitudinalaxis of the barrel 12. As explained in the above-identified applicationSer. No. 09/506,484 filed Feb. 17, 2000, and in application Ser. No.09/745,751 filed Dec. 21, 2000, this combined or bidirectional motion isvery advantageous because as the needle 86 penetrates the skin and thetissues and advances to the vein, its simultaneous rotation insures thatthe patient suffers less pain. In addition, it prevents the needle 86from bending and insures that the needle advances precisely in thedirection and to the location desired by the clinician.

[0049] The needle 86 must be advanced sufficiently so that the frontportion 94 is in fluid communication with the vein as well. The frontportion 94 is thin enough so that it slips easily through the sidewallsof the vein. As discussed above, needle 86 is hollow and has an openingat its tip. A second opening may be provided on the needle 86 under thefront end 94. When the needle 86 and front end 84 are inserted into thevein, blood from the vein flows into the needle 86 and oozes out of thissecond opening, under the front end 94. Since the catheter 52 istranslucent, this blood is easily visible to the clinician. Moreover,since the needle 86 is hollow, some of the blood also flows back in thehousing where it becomes visible as well. This provides confirmationthat the needle 86 and the catheter member 52 are properly positioned inthe vein.

[0050] If for any reason the clinician has to move to a differentinfusion site, he can withdraw the needle from the patient. If thismotion occurs before the control member 100 reached front key 30 thenthe clinician can merely release the control member 100 and the catheterassembly 21 is then automatically returned to the retracted position bythe spring 23. If this motion is desired after the front key 30 isreached, then the clinician must first unlock the control member fromthe front key by pressing inwardly on wing 110.

[0051] Once the catheter assembly 21 is returned to its retrievedposition, the device 10 can be rested on a flat surface and theclinician can go on with other tasks (such as prepping the new site)without fear of needlesticks even if the needle 86 has beencontaminated.

[0052] After the needle 86 and the catheter member 52 are properlypositioned in the vein, the needle 86 is withdrawn as follows. Theclinician shifts his forefinger to rest on the front end 94 of thecatheter member 52. The rest of his fingers are still wrapped around thebarrel 12. In this position, the clinician unlocks the control member100 as discussed above and releases it. The spring 23 forces the needlemember 54 to withdraw telescopically and separate from the catheter 52.The needle member 54 and the piston 50 are then snapped back to theretracted position. During this motion, the clinician holds the cathetermember 52 in place (i.e., inserted in the vein). Thus, the clinicianneeds to use only a single hand from the beginning of the process untilthe catheter member 54 is established in the vein and is separated fromdevice 10. As explained above, in prior art devices this same operationrequires the use of two hands.

[0053]FIG. 3 shows the catheter member 52 being removed from the needlemember 54.

[0054]FIG. 4 shows the catheter member 52 being separated from the restof the device 10.

[0055]FIG. 5 shows the catheter assembly 21 without the catheter member52 in the retracted position.

[0056] Once the device 10 is in the retracted position of FIG. 5, it canbe disposed. The catheter member 52 can be connected to a standard IVtube by attaching to a standard Luer lock, or by using other well knownmeans.

[0057] Importantly, in many instances the clinician may want to insurethat once its catheter member 54 has been properly established, thedevice 10 is not reused in any way and that the needle member 54 staysin the retracted position. This is accomplished by providing a disabledcondition for the device in which the control member 100 is inoperativeand cannot be used to advance the needle. One manner in which thisfeature can be implemented is to make the intermediate portion 106 ofthe control member 100 frangible. Then, once the catheter member 52 isproperly established in the vein, the top body 102 is broken off fromthe bottom body 104. Once this step is completed, the piston 50 and theneedle member 54 are trapped inside the barrel 12 and cannot be removedwithout breaking the barrel.

[0058] The device may be used in a different manner as well. Forexample, if the clinician does not want to take advantage of thesimultaneous translation and rotation of the needle member 54, he canadvance the catheter assembly 21 from the retracted to the extendedposition first, and then with the needle member being fully extended, hecan start inserting the needle 86 through the skin toward the selectedvein. For this type of operation, since the rotation of the needle 86 isnot required, the knob 64 and the groove 26 may be omitted.

[0059] Other modifications may be made to the device 10 as well. Forexample, the means for locking the control member 100 either in theretracted position, the extended position, or both, may be omitted.

[0060] While the invention has been described with reference to severalparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles of the invention. Accordingly,the embodiments described in particular should be considered asexemplary, not limiting, with respect to the following claims.

I claim:
 1. A device for establishing an IV catheter by a cliniciancomprising: a housing sized and shaped to fit in the hand of theclinician; a catheter assembly including a catheter member with a frontportion adapted to be inserted into the vein of a patient; and a controlmember adapted to reciprocate said catheter assembly within said housingbetween a retracted position in which said catheter assembly iscompletely contained in said housing and an extended position in whichsaid catheter member extends outwardly of said housing.
 2. The device ofclaim 1 wherein said catheter member is removably attached to saidcatheter assembly so that it can be removed in said extended position.3. The device of claim 1 wherein said catheter assembly includes aneedle member including a needle which extends outwardly of said housingwhen said catheter member is in the extended position, said needle beingarranged and constructed for insertion in the vein, said catheter memberbeing telescopically associated with said needle member.
 4. The deviceof claim 3 wherein said catheter member is removably attached to saidneedle member.
 5. The device of claim 1 wherein said catheter member andsaid housing cooperate to rotate said about a longitudinal axis as saidcatheter assembly is reciprocated by said control member.
 6. The deviceof claim 1 further comprising locking means for locking said catheterassembly with respect to said housing.
 7. The device of claim 6 whereinsaid locking means is adapted to lock said catheter assembly in saidretracted position.
 8. The device of claim 6 wherein said locking meansis adapted to lock said catheter assembly in said extended position. 9.The device of claim 1 further comprising disabling adapted toselectively disable said catheter assembly within said housing toprevent said catheter assembly for being moved extend outside saidhousing.
 10. A device adapted to establish a catheter for providing IVinfusions to a patient through a vein, said device comprising: acylindrical housing having a front end, a rear end and a cylindricalsurface extending therebetween; a catheter assembly including a needlemember with a needle and a catheter member removably attached to saidneedle member and telescopically arranged on said needle; and controlmeans for reciprocating said catheter assembly between a retractedposition wherein said catheter assembly is completely disposed withinsaid cylindrical and an extended position wherein said needle and saidcatheter member are operative to be inserted in the vein.
 11. The deviceof claim 10 wherein said catheter assembly further comprises a piston,said needle member and said catheter member being connected to saidpiston.
 12. The device of claim 10 further comprising rotating meansadapted to rotate said catheter assembly about an axis as said catheterassembly is reciprocated by said control means.
 13. The device of claim10 further comprising a first locking means for locking said catheterassembly in said retracted position.
 14. The device of claim 10 furthercomprising a second locking means for locking said catheter assembly insaid extended position.
 15. The device of claim 10 further comprisingcontrol disabling means adapted to disable said control means to preventsaid catheter assembly from being moved to extend outside saidcylindrical housing.
 16. The device of claim 10 further comprisingbiasing means for biasing said catheter assembly toward said retractedposition.
 17. An IV catheter delivery device comprising: a cylindricalhousing with a housing front end, a housing rear end and a cylindricalhousing extending therebetween; a catheter assembly disposed in saidbarrel and including a catheter member with a catheter front end adaptedto be inserted in the vein of a patient; a control member adapted toselectively move said catheter assembly from a retracted positionwherein said catheter front end is disposed completely within saidcylindrical housing and an extended position wherein said catheter frontend extends outwardly of said housing front end; and biasing means forbiasing said catheter assembly toward said retracted position.
 18. Thedevice of claim 17 further comprising means for rotating said catheterassembly as said cardiac assembly is advanced toward said extendedposition.
 19. The device of claim 17 further comprising a needle memberhaving a needle adapted to be inserted into a vein, said catheter memberbeing telescopically mounted on said needle.
 20. The device of claim 17wherein said catheter front end is flexible.